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UnknownNCT02932501

Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns of Patients With Medication-related Osteonecrosis of the Jaw (MRONJ) and Their Outcome

Status
Unknown
Phase
Study type
Observational
Enrollment
518 (actual)
Sponsor
AO Clinical Investigation and Publishing Documentation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and antiangiogenic drugs , degree and extension of osteonecrosis, osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.

Detailed description

Approximately 500 patients diagnosed with medication-related osteonecrosis of the jaw will be enrolled in the study. Patients will undergo standard (routine) of care treatment, either conservative or surgical or both, and followed up during one year after the initiation of the treatment. Treatment outcome (development of the condition), pain and complications will be collected and documented over the duration of the registry.

Conditions

Interventions

TypeNameDescription
PROCEDUREConservative treatmentDisinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
PROCEDURESurgical treatmentSuperficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage
PROCEDUREAdjuvant non-surgical treatmentHyperbaric oxygen therapy Pentoxifylline and tocopherol Ozone therapy Low level laser therapy Pain relief Anti-inflammatory treatment Platelet rich plasma Parathyroid hormone and teriparatide Bone morphogenetic protein

Timeline

Start date
2017-08-14
Primary completion
2023-10-13
Completion
2024-04-01
First posted
2016-10-13
Last updated
2024-03-20

Locations

14 sites across 10 countries: United States, Finland, Germany, Netherlands, Qatar, Romania, Slovenia, South Korea, Spain, Switzerland

Source: ClinicalTrials.gov record NCT02932501. Inclusion in this directory is not an endorsement.